FDAnews Drug Daily Bulletin


Jan. 19, 2005

The FDA has issued a warning letter to the Respi Care Group of Puerto Rico alerting the company it has committed "serious violations" of the Federal Food, Drug, and Cosmetic Act.

Respi's operation of manufacturing compounded inhalation solution products is more akin to that of a drug manufacturer, the FDA said in the letter. Products made by Respi -- albuterol sulfate and budesonide inhalation -- are sold in the same strength as the commercially available products, the agency said.

In addition, since the start of Respi's operation in 2002, the company has produced volumes of inhalation solutions that are inconsistent with that of a pharmacy engaged in the traditional practice of extemporaneous pharmacy compounding, the FDA said.

Essentially, Respi has been producing copies of commercially available, FDA-approved drugs, the agency stated. Moreover, Respi continues to manufacture and distribute products "with virtually no regard to current good manufacturing practice requirements," the FDA said.

Among the specific violations listed in the letter: inadequate labeling of products; failure to establish and follow written procedures designed to prevent microbiological contamination of products; failure to perform qualification studies on its steam sterilizer; insufficient gowning of employees handling sterilized materials; and failure to assure conformance to sterility requirements for each batch of drug purporting to be sterile.

FDA based its warning letter on an inspection conducted June 9-17, 2004. The agency said a letter Respi filed in July 2004 in response to the inspection was inadequate in addressing its deficiencies. Respi said that it had no comment on the letter.

To view the warning letter, go to http://www.fda.gov/foi/warning_letters/g5139d.htm (http://www.fda.gov/foi/warning_letters/g5139d.htm).